[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605808":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":56,"collaborators":60,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":20,"enrollmentInfo":72,"targetDuration":20,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":88,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"AC Camargo Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Belzutifan (WELIREG™)","EXPERIMENTAL","Patients with von Hippel-Lindau Syndrome presenting with lesions or neoplasms requiring treatment with oral Belzutifan (WELIREG™)",[13],"Drug: Belzutifan",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Belzutifan","Patients with Von Hippel-Lindau Syndrome presenting with lesions or neoplasms requiring treatment with oral Belzutifan.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"José Claudio Casali da Rocha, Head of Oncogenetics","CONTACT","+55 41 98505 8585","casali.rocha@accamargo.org.br",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"José Reinaldo De Oliveira Junior","+55 31 99549 3678","j.junior@accamargo.org.br",[32],{"facility":5,"status":33,"city":34,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","São Paulo","01509900","Brazil","BR",{"type":39,"coordinates":40},"Point",[41,42],-46.63611,-23.5475,{"lat":42,"lon":41},[45,50,52,54],{"name":46,"role":24,"phone":47,"phoneExt":48,"email":49},"Giovana Tardin Torrezan, Research Coordinator","+55 11 2189 5020","5020","cep_accamargo@accamargo.org.br",{"name":51,"role":24,"phone":47,"phoneExt":48,"email":49},"Sandra Almeida, Administrative CEP",{"name":23,"role":53,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"name":28,"role":55,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","José Claudio Casali da Rocha","Head of Department of Oncogenetics",[61],{"name":5,"class":6},"100605808","phase-2-real-world-effectiveness-and-pharmacogenetics-of-belzutifan-in-vhl-syndrome-the-believe-vhl-trial-100605808",false,"NCT07167329","Real-World Effectiveness and Pharmacogenetics of Belzutifan in VHL Syndrome: The BELIEVE-VHL Trial","The BELIEVE-VHL Trial: A Real-world Longitudinal Study on Belzutifan's Effectiveness, Pharmacogenetics, and Pharmacoeconomics in Von Hippel-Lindau (VHL) Syndrome Using the HIF2α Inhibitor Belzutifan","BELIEVE-VHL","Inclusion Criteria:\n\n* Age ≥ 14 years.\n* Clinical or genetic confirmation of von Hippel-Lindau (VHL) syndrome.\n* Presence of measurable or progressive VHL-associated tumors, as defined by RECIST 1.1 or disease-specific imaging criteria.\n* ECOG performance status of 0-2.\n* Adequate bone marrow, hepatic, and renal function as defined by laboratory reference values.\n* Ability to swallow oral medication.\n* Provision of written informed consent prior to enrollment.\n\nExclusion Criteria:\n\n* Age \\\u003C 14 years.\n* Absence of a confirmed diagnosis of von Hippel-Lindau (VHL) syndrome.\n* Presence of an active malignancy outside the VHL tumor spectrum within the past 3 years, except for adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies considered cured for \\>2 years.\n* Known hypersensitivity or allergic reaction to belzutifan or any excipient in the formulation.\n* History of severe or uncontrolled cardiovascular disease, including but not limited to unstable angina, myocardial infarction within the past 6 months, congestive heart failure requiring treatment, or uncontrolled hypertension.\n* Active infectious diseases, including HIV, hepatitis B, or hepatitis C.\n* Immunosuppressed status, whether due to underlying disease or ongoing therapy.\n* History of significant bleeding disorders, including bleeding diathesis, thrombocytopenia, or coagulopathy.\n* Radiotherapy administered within 4 weeks prior to study enrollment.\n* Major surgical procedure, including for VHL-related tumors, within 4 weeks prior to study enrollment, or immediate need for surgical intervention for tumor management.\n* Malabsorption secondary to prior gastrointestinal surgery or active gastrointestinal disease.\n* Current use of concomitant medications known to interact with belzutifan and significantly alter its bioavailability.\n* Anticipated low adherence to or planned interruption of belzutifan therapy.","ALL","14 Years",{"count":73,"type":74},100,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","The BELIEVE-VHL Trial is a prospective real-life study designed to evaluate the therapeutic effects, benefits, and adverse effects of belzutifan, as well as the timing of treatment response and disease progression in patients with von Hippel-Lindau (VHL) syndrome.",[80,81,82,83,84,85,86,87],"Von Hippel Lindau","Von Hippel Lindau Disease","Von Hippel Lindau-Deficient Clear Cell Renal Cell Carcinoma","Hemangioblastoma (HB) of the Central Nervous System (CNS)","PNET","Retinal Angiomatous Proliferation","Pheochromocytoma\u002FParaganglioma","Endolymphatic Sac Tumor",[17,89,90,91,92],"von Hippel-Lindau","Renal Cell Clear Carcinoma","Hemangioblastoma of Central Nervous System","Pharmacogenetics","2025-09-09",{"date":95,"type":96},"2025-09-11","ACTUAL",{"date":98,"type":96},"2024-01-01",{"date":100,"type":74},"2030-01-01",{"name":58,"class":6},1]